Study Evaluating the Safety and Efficacy of Autologous Non-Hematopoietic Peripheral Blood Stem Cells in COVID-19 (SENTAD-COVID)
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|ClinicalTrials.gov Identifier: NCT04473170|
Recruitment Status : Completed
First Posted : July 16, 2020
Last Update Posted : July 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Disease 2019 (COVID-19)||Biological: Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) Drug: COVID-19 standard care||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Parallel assignment involving two groups of participants:
|Masking:||None (Open Label)|
|Masking Description:||None (open-label)|
|Official Title:||Adaptive Open-label Study Evaluating the Safety and Efficacy of Autologous Non- Hematopoietic Peripheral Blood Stem Cells Therapy in COVID-19 Outbreak in Abu Dhabi, 2020 (SENTAD-COVID Study)|
|Actual Study Start Date :||April 4, 2020|
|Actual Primary Completion Date :||May 20, 2020|
|Actual Study Completion Date :||July 14, 2020|
Experimental: Group A
Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy as add-on COVID-19 standard care.
Biological: Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)
SENTAD-COVID Study intervention consists of Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy through jet nebulization in addition to standard care. The NHPBSC were characterized as CD90+, CD133+, Oct-4+ (pluripotent markers), and CD45-, CD71-, based on multiparameter flow cytometry.
Other Name: UAECell19
Active Comparator: Group B
COVID-19 Standard care.
Drug: COVID-19 standard care
UAE National Guidelines for Clinical Management and Treatment of COVID-19.
Other Name: Current COVID-19 standard care in the UAE
- Adverse reactions incidence. [ Time Frame: Day 0 - 28 ]Proportion of participants with treatment-related Adverse Event as assessed by CTCAE v5.0.
- Rate of mortality within 28-days. [ Time Frame: Day 0 - 28 ]Incidence of deaths within 28-days in enrolled patients.
- Time to clinical improvement on a seven-category ordinal scale. [ Time Frame: Day 0 - 28 ]Days from administration of the Investigational Product to improvement of seven-category ordinal scale by at least 2 points.
- Assessment of the immune response profile. [ Time Frame: Days 0, 14, and 28 ]Immune response profile characterized according the biomarkers: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD20, CD25, CD27, CD28, CD38, CD45, CD45RA, CD45RO, CD56, CD57, CD66b, CD123, CD127, CD161, CD294, CCR4, CCR6, CCR7, CXCR3, CXCR5, HLA-DR, IgD, and TCRγδ, for the identification of immune cells and subsets analysis; and the humoral Immune profile: IgG, IgA, IgM levels.
- Assessment of acute-phase serum markers. [ Time Frame: Days 0, 14, and 28 ]Complete Blood Counts (CBC), Acute phase proteins and Inflammatory markers: CRP, ESR, LDH, Procalcitonin (PCT), Ceruloplasmin, Haptoglobin, alpha 1 antitrypsin, IL-6, ferritin C3, PT, fibrinogen and D-dimer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473170
|United Arab Emirates|
|Abu Dhabi Stem Cells Center|
|Abu Dhabi, United Arab Emirates, 4600|
|Principal Investigator:||Yendry Ventura Carmenate, M.D.||Abu Dhabi Stem Cells Center (ADSCC)|